Tobramycin-Dexamethasone Versus Tobramycin-Dexamethasone Plus Ketorolac After Phacoemulsification Surgery

• Sponsor: Veroia General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00992355
• Collaborator: (none)
• Enrollment: 97
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 32.8

Study Details

Study Description

Brief Summary

This randomized controlled trial compares two regimens of topical therapy:

• tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four times/day

• combination of tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four times/day, plus Ketorolac tromethamine 0.5% (Acular®, Allergan), one drop three times/day. The topical treatment is administered for 28 days after phacoemulsification.

Patients are independently assessed by two ophthalmologists. On day 28, patients are evaluated for

• corneal edema

• conjunctival redness

• anterior chamber reaction. Moreover, the cases necessitating continuation of treatment are compared in the two groups on day 28 and 42.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Drug: Tobramycin 0.3% - Dexamethasone 0.1%; Drug: Tobramycin 0.3% - Dexamethasone 0.1% plus Ketorolac tromethamine 0.5%	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 97 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Tobramycin 0.3% - Dexamethasone 0.1% Versus Tobramycin 0.3% - Dexamethasone 0.1% Plus Ketorolac Tromethamine 0.5% After Phacoemulsification Surgery. A Randomized Trial
• Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Tobramycin 0.3% - Dexamethasone 0.1%	Drug: Tobramycin 0.3% - Dexamethasone 0.1%
Active Comparator: Tobramycin-Dexamethasone plus Ketorolac tromethamine	Drug: Tobramycin 0.3% - Dexamethasone 0.1% plus Ketorolac tromethamine 0.5%

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 95 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Phacoemulsification (due to cataract)

• Uneventful phacoemulsification surgery

Exclusion Criteria:

• Disruption of the anterior lens capsule

• Age-related macular degeneration

• Proliferative diabetic retinopathy

• Glaucoma

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Ophthalmology, Veroia General Hospital	Veroia		Greece	59100

Sponsors and Collaborators

• Veroia General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00992355
• Other Study ID Numbers: VGH-EYE01
• First Posted: Oct 9, 2009
• Last Update Posted: Oct 9, 2009
• Last Verified: Oct 1, 2009

• Keywords provided by , ,: Cataract; Phacoemulsification; Treatment duration
• Additional relevant MeSH terms: Cataract; Tobramycin; Dexamethasone; Dexamethasone acetate; Ketorolac; Ketorolac Tromethamine; BB 1101

Study Results

No Results Posted as of Oct 9, 2009